MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B2070-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.Obtaining the device may have further aided the analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the mid brachial that was non-tortuous, non-calcified and 90% stenosed.The armada 35 balloon dilatation catheter would not deflate after several attempts over a span of 30 minutes, even using the indeflator.A syringe was also used to no avail.Finally, a guide wire was used to puncture the balloon so that it could be removed from the anatomy.When the device was removed from the anatomy, the balloon could still not be deflated.Another same size armada was used to successfully complete the procedure.It was reported that the armada was inflated to 9 atmospheres.There was no difficulty reported during removal of the protective sheath and the device was prepped according to the instructions for use.Although there was a delay in the procedure it was not clinically significant and there were no adverse patient effects.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6513486
• Report Number: 2024168-2017-03497
• Device Sequence Number: 10928134
• Product Code: LIT
• UDI-Device Identifier: 08717648155369
• UDI-Public: (01)08717648155369(17)200430(10)61109G1
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: B2070-060
• Device Lot Number: 61109G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention